FDA inspection
Alkem Laboratories Limited: FDA inspection ending Jul 7, 2022
FDA inspection 1173754 · Official Action Indicated (OAI) · Dhar
Key facts
| Inspection ID | 1173754 |
|---|---|
| Firm | Alkem Laboratories Limited |
| FEI number | 3016480976 |
| Address | Plot A-17, I.S.E.Z. Phase Ii, Industrial Area, Sector-Iii, Pithampur |
| City | Dhar |
| Fiscal year | 2022 |
| Inspection end date | Jul 7, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Generic Drug Evaluation |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data